The European Commission's decision concerning veterinary medicinal products containing zinc oxide

06 July 2017

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

According to the decision, a member state may defer the withdrawal of the marketing authorisations if it considers that the immediate withdrawal may have adverse impact on its territory given the lack of availability of alternatives and the change required in pig farming practices. The period of deferral must not exceed five years from 26 June 2017; thus, the decision must be implemented no later than 26 June 2022.

The decision also implies that the member states must take account of the scientific conclusions set out in Annex II to the decision when they assess the efficacy and safety of veterinary medicinal products containing zinc oxide to be administered orally to food producing species.

As a result of this decision, the Danish Medicines Agency will follow the changes to the methods for the prevention of diarrhoea in young pigs in the weaning transition period and regularly assess when it would be expedient to implement the decision of the European Commission.

Links

Commission implementing decision

Annexes to the decision

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